MSKCC has a multi-tiered protocol review system that is overseen by the Research Council, a multidisciplinary Institutional committee whose charge is to review all clinical research protocols for quality, science, Institutional priority and programmatic fit, and resource allocation. The Research Council (RC) reports directly to the Physician-in-Chief and works closely with the Office of Clinical Research (OCR) to set policy and monitor all protocols that are a part of the Clinical Research and Prevention, Control and Population Research programs. The Research Council has seven subcommittees that are charged with evaluating specific technical or scientific aspects of a study such as psychosocial and pain measures, human tissue utilization, and gene therapy. In addition, RC reviews the overall clinical research portfolio for content and balance, plans for future changes in direction and content of research analysis, discusses institutional strengths and weaknesses in the clinical research sphere, and refines procedures involved in protocol generation and review. Recent examples of policy-related issues discussed at the Research Council include the Institutional Data Safety and Monitoring Policies, the allocation of human tissue resources for use in pilot studies, and Institutional policies on research billing procedures. RC, which is chaired by David P. Kelsen, M.D., has 24 members who represent a crosssection of the leading investigators involved in the Clinical Research, Prevention, Control and Population Research, Imaging and Radiation Sciences, Cancer Biology and Experimental Therapeutics, and Immunology and Transplantation Programs.